10 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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FlowArt® Needle-Free Split Septum Valve
FDA 510(k)
FDA Class 2
·General Hospital
FLOWART NEEDLE-FREE SPLIT SEPTUM VALVE
FDA Adverse Event
Malfunction
·ASSET MEDIKAL TASARIM SAN. TIC. A.S.·Product code FPA·July 24, 2025
Able Medical Devices Valkyrie Thoracic Fixation System
FDA 510(k)
FDA Class 2
·Orthopedic
SIEMENS INFINITY MODULAR MONITORS, MODELS SC 8000, SC 7000 & SC 9000XL & SIEMENS INFINITY EXPLORER
FDA 510(k)
FDA Class 2
·Cardiovascular
TRUPATH BIOPSY DEVICE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code FCG·November 6, 2008
UNKNOWN ZIMMER GLENOSPHERE
FDA Adverse Event
Malfunction
·ZIMMER, INC.·Product code HSD·August 10, 2011
IMMERSION HYDROBATH
FDA Adverse Event
Malfunction
·INVACARE CLEVELAND STREET·Product code ILJ·July 12, 2013
5.5 HEALIX ADVANCE KNTLS PEEK
FDA Adverse Event
Injury
·DEPUY MITEK LLC US·Product code MAI·May 25, 2021
SpF PLUS-Mini (60 ¿A/W) Implantable Spinal Fusion Stimulator SpF PLUS-Mini Implantable Fusion Stimulators are indicated as a spinal fusion adjunct to increase the probability of fusion success in 1 or 2 levels
FDA Enforcement
Class I
·Terminated·Zimmer Biomet, Inc.·November 7, 2018
Quadra Assura MP, Sterile EO, Model #/ Part #: CD3269-40/100043177; CD3269-40Q/100043178; CD3271-40/100043130; CD3271-40Q/100043191; CD3369-40C/100080339, 100080478; CD3369-40Q/100080439, 100080476, 100105528; CD3371-40/100078814, 100079232, 100079513; CD3371-40C/100078639, 100079231, 100079478, 100105493, 100105494; CD3371-40Q/100078815,100079282, 100079479, 100138237; CD3371-40QC/100078640, 100079165, 100079506, 100079541, 100105505, 100105506, 100138173, 100138179, 100138222, 100138234; CD3387-40C/100105525; CD3387-40QC/100138158
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018